BioCryst Reports New Data from Its Phase 2 Forodesine Study in Patients with Chronic Lymphocytic Leukemia at the 52nd Annual American Society of Hematology Meeting
Study Results Confirm Clinical Activity of Forodesine Against CLL
In this Phase 2, open-label, single-arm, multi-center study, forodesine was administered orally at 200 mg twice-daily for 28-day cycles in previously treated CLL patients. The primary endpoint of the study was overall response rate. An analysis conducted after all patients were followed through ≥6 months showed that six of 23 response-evaluable patients demonstrated a partial response to forodesine, resulting in a response rate of 26 percent. Forodesine 200 mg orally-administered twice-daily was generally safe and well-tolerated in this study. The pattern, frequencies and severity distribution of adverse events were generally consistent with CLL-associated poor bone marrow function and immunodeficiency, prior therapies and co-morbidities.
"We are encouraged by these results, which support the potential role
for forodesine and other purine nucleoside phosphorylase inhibitors in
the treatment of patients with hematological malignancies. We believe
further evaluation of oral PNP inhibitors in combination with other
anti-leukemic agents for CLL is warranted," said Dr.
The data will be presented during a poster session scheduled for today,
- Presentation Number 1397: "Forodesine, a Purine Nucleoside Phosphorylase (PNP) Inhibitor, Shows Clinical Activity in a Phase 2 Trial in Patients with Previously Treated CLL — Interim Analysis".
The abstract is available and can be viewed online through the ASH Web site at www.hematology.org/, and the poster is available on the BioCryst Web site at www.biocryst.com.
About forodesine
Forodesine is an orally-available transition-state analog inhibitor of purine nucleoside phosphorylase (PNP), a purine salvage pathway enzyme that is essential for the proliferation of T-cells and B-cells. Typically, T- and B-cells are an essential part of the body's immune system, but when they multiply uncontrollably they can cause various forms of cancer. Inhibiting PNP produces selective suppression of T- and B-cells, inducing apoptosis in both types of cells. For more information about forodesine, please visit BioCryst's Web site at http://www.biocryst.com/forodesine.
About BioCryst
Forward-Looking Statements
This press release contains forward-looking statements, including
statements regarding future results, performance or achievements. These
statements involve known and unknown risks, uncertainties and other
factors which may cause our actual results, performance or achievements
to be materially different from any future results, performances or
achievements expressed or implied by the forward-looking statements.
These statements reflect our current views with respect to future events
and are based on assumptions and subject to risks and uncertainties.
Given these uncertainties, you should not place undue reliance on these
forward-looking statements. Some of the factors that could affect the
forward-looking statements contained herein include: that development
and commercialization of forodesine may not be successful; that we or
our licensees may not be able to enroll the required number of subjects
in planned clinical trials of our product candidates and that such
clinical trials may not be successfully completed; that BioCryst or its
licensees may not commence as expected additional human clinical trials
with our product candidates; that our product candidates may not receive
required regulatory clearances from the
BCRXW
or
WCG
Catherine
Collier Kyroulis, 212-301-7174 (media)
Source:
News Provided by Acquire Media